FDA product code PFT: Reagents For Molecular Diagnostic Test Systems

PFT is the FDA product code for reagents for molecular diagnostic test systems. It is a Class I device, regulated under 21 CFR 862.3800 and reviewed by the Clinical Toxicology panel. Devices under PFT reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it. FDA has posted 2 recalls for PFT devices, 1 initiated in the last five years.

Definition

A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.

Classification

Recalls for PFT devices

2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-10-28.

Frequently asked questions

What is FDA product code PFT?

PFT is the FDA product code for reagents for molecular diagnostic test systems. It is a Class I device, regulated under 21 CFR 862.3800 and reviewed by the Clinical Toxicology panel.

What device class is PFT?

Class I, regulation 21 CFR 862.3800. Typical premarket route: 510(k) exempt.

Have PFT devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2025-10-28.

Next steps

• Run an FDA pathway report with predicate devices for product code PFT
• Run a recall and safety report across every PFT manufacturer
• Watch product code PFT for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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